Regulatory Affairs Specialist (IVD / Medical Devices)

Location: Warrington/ UK-based (Remote or Hybrid) Contract: 12 months Hours: 37.5 per week, Monday-Friday (flexible) Start date: ASAP Salary: £60 per hour

Are you an experienced Regulatory Affairs professional with deep expertise in IVD or Medical Device regulations across EMEA? This is an exciting opportunity to take a leading role in supporting regional regulatory strategies, ensuring compliance, and enabling market growth for innovative life science products.

About the Role

As a Regulatory Affairs Specialist, you will lead and manage product and establishment registrations across EMEA, supporting both new market access and ongoing compliance activities. You will collaborate cross‑functionally in a highly international environment, guiding teams and stakeholders while maintaining strong relationships with regulatory authorities and distribution partners.

This role offers the flexibility of remote or hybrid working within the UK, with occasional travel required for escalations or key business needs.

Key Responsibilities

Lead national product and establishment registrations across EMEA regions. Develop and execute registration strategies aligned with commercial and global regulatory objectives. Maintain strong professional relationships with regulatory bodies and distributors. Perform registrations using relevant national databases and track progress t...